RECALL DATABASE

Tretinoin Cream Recall: Northstar Rx prescription-only

Announced 2026-10-14 · FDA

FDA recall for Sun Pharmaceutical Industries Inc Tretinoin Cream USP, 0.05%, 45 g tube (Rx only) distributed nationwide in the US. The lot AD96184 has an expiration date of 12/31/2026 and failed impurities/degradation specifications. No corrective action is provided in the available details.

BrandSUN PHARMACEUTICAL INDUSTRIES INC
ProductTretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.
ReasonFailed Impurities/Degradation Specifications
Severitylow
Units affectedN/A
DistributionUS Nationwide.
AgencyFDA

WHAT YOU SHOULD DO

  1. Do not use any product from Lot AD96184.
  2. Contact the pharmacy or Northstar Rx for return or replacement instructions.
  3. If you have used the product and have concerns, consult your healthcare provider.
  4. Preserve packaging and records in case they are needed for return or reporting.

How to identify the recalled item

Lot / date codesLot # AD96184, Exp Date: 12/31/2026.
Lot / date codesLot # AD96183, Exp Date: 12/31/2026.

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

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This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.