The Recall Desk
ModerateFDA (Drugs)·D-1207-2019·Announced 2018-12-26

Sun Pharmaceutical Recalls Subpotent Absorica LD Isotretinoin Capsules

Sun Pharmaceutical Industries is recalling Absorica LD (Isotretinoin) capsules because the active ingredient content was lower than the required specification limit.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug (lower than specification), which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Absorica LD (Isotretinoin) Capsules 30 mg USP. The recall involves 47,520 prescription packs distributed nationwide in the USA. The specific lot affected is 17F28AA with an expiration date of 1/2020.

The recall was initiated because the isotretinoin content in the product was found to be lower than the specification limit during routine product monitoring. This condition is classified as a subpotent drug issue.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of distribution for a refund or replacement.

The recalled product

Product
ABSORICA LD (ISOTRETINOIN)
Brand
ABSORICA LD
Affected units
47,520

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 17F28AA
  • Exp 1/2020

UPCs (1)

  • 310631117313

Distribution

Distributed nationwide across the United States.

Same brand · ABSORICA LD